Medical Research

Medical Research

Medical research is conducted by scientists who are experts in a range of fields, and who conduct lab experiments and clinical trials to advance understanding of diseases and treatments. Your healthcare provider is a good source for information about clinical trials that may be appropriate for you.

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Clinical trials retain very specific participation guidelines. Establishing and maintaining these guidelines is a critical part of producing meaningful and reliable results. The factors that allow someone to participate in a clinical trial are called "inclusion criteria," while those that disallow someone are called "exclusion criteria." Typical criteria include age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.

Some people think that the care given to people who participate in clinical trials is not good. Quite the opposite is true. Doctors must follow a very thorough and detailed plan called a protocol and report on how the plan was followed. People who are in clinical trials get excellent care and are followed very closely by doctors and their staff.

A clinical trial is a medical research study that tests new ways to prevent, screen, diagnose or treat a disease. There are five main reasons you should talk to your oncologist about a clinical trial for cancer:

Complete care - The "standard of care" is what the medical community agrees is the treatment for a specific type of cancer given a person's overall health. Clinical trials always provide treatment that is the standard of care or better. For example, in a randomized Phase III trial for a promising new chemotherapy drug, some participants would get the treatment under study while others get the standard of care. Or some participants would get the current standard of care plus the treatment under study, while others get just the current standard of care.

Careful monitoring - Because the promising new treatment is being carefully studied, participants are also carefully monitored by healthcare professionals to see how they are doing and to watch for side effects. So people enrolled in clinical trials tend to talk with their healthcare professionals more often and are watched more carefully than people not involved in a trial.

Safety first - Requirements for clinical trials are strictly managed by the U.S. Food and Drug Administration (FDA). Before a drug is approved for testing in humans, the FDA ensures that it has gone through strict testing protocol in laboratory animals.

Close to home - Most people are familiar with the tremendous research being conducted all over the country at research institutions, but in fact many community cancer centers offer opportunities for people to participate in clinical trials. Depending on the type of clinical trial you seek, you may have many options that do not require you to travel.

Scientific advancement - Without clinical trials, there is no progress toward cures for cancer. By participating in scientific research through a clinical trial, you can help future cancer patients gain access to new, better treatments. People who are treated through clinical trials have access to the best new treatments before the general public. Making the decision to participate in a cancer clinical trial also helps you play a more active role in your own healthcare.

Some people think that doctors randomly make up clinical trials. However, it takes years of thought and planning to have a clinical trial accepted by the U.S. Food and Drug Administration so that it can recruit participants. Clinical trials are sponsored by organizations, institutions, pharmaceutical and biotechnology companies, the government and nonprofit groups who want to improve current cancer treatments. Some trials are "investigator initiated," which means a researcher or doctor created the trial, but these trials face the same strict requirements.

There are generally known and unknown risks associated with clinical trials, such as:

There may be unpleasant, serious, or even life-threatening side effects resulting from the treatment.

The treatment may not be effective for the participant.

The protocol may require more of the participant's time and attention than a standard treatment. (Participants may need to visit the study site on a regular basis, be subjected to additional tests, get more treatments than are normally necessary, stay in the hospital and/or follow complex dosage requirements).

When there is an available treatment to help a person with cancer, that person will always receive at least that level of treatment in a clinical trial. Very few trials use placebos, or things that look like "real" treatments but have no effect. People with cancer who are no longer helped by current approved treatments may find that a clinical trial provides hope.

The process of being evaluated for a clinical trial provides lots of information about what you will experience. People in clinical trials also receive a detailed "informed consent" document. This document describes everything from treatment procedures and schedules to possible risks and benefits.

Many community clinics and doctors' offices have started participating in clinical trials for breast cancer to allow participants to enter studies close to home, thus, avoiding the costs and burdens of travel to major cancer centers. However, finding a geographically convenient study for which you qualify is not always the possible. Either way, it's important to do your homework. There are several online searchable databases that you can use to match your situation to trials currently enrolling people. These include: